Web-based electronic data capture software for data management of multi-center

research studies, developed by

• A proven Contract Research Organization (CRO)

• Provides a full range of product development services to device and pharmaceutical companies

• Serves major clients such as device giant Roche Diagnostics and women’s health leader Hologic

BSI’s headquarters in Tampa

About BioStat International…

• Respect and support to our clients

• Embracing change and innovation

• Taking clients’ priorities as our own

• Aiming for affordability and environmental responsibility

• Knowing that every circumstance creates its own opportunity

BSI’s culture…

“Most clinical trial software is geared towards well-funded industry research. BSI recognized a void in the market for a well-managed and affordable web-based data management solution. We developed software to fill that niche.”

-- Maureen Lyden, M.S. President and CEO

BioStat International, Inc.

Our niche…

We wanted a name for our new software that reflected our company’s culture.

• “Red Cap 42” was a baggage handler at Grand Central Station during World War II.

• He shared a philosophy of service in the way he lived and treated others.

• We believe his philosophy was very much like our own.

Look up…….seek wisdom.

Look in……..grow as a person.

Look out……help others.

We were inspired by the story of Red Cap 42.

Hence, our name.

You’ll work with an experienced CRO to

design your eCRF, manage your hosting, and

provide statistical expertise to your data management.

You’ll get up to speed quickly with rED Cap.

This system is easy and intuitive to use, with

flexibility, adaptability and sophisticated

data checking capability.

Why will you like rED Cap?

• Observational studies

• Pre-clinical

• R&D

• Post-Marketing/Marketing

• Registries

rED Cap is not just for regulated clinical trials…it’s also ideal for

• Works with iPad, laptops, & supported desktop browsers (Explorer, Firefox, Google, Safari 5)

• Fully supports web page display & data segregation

• Includes ODM v1.3 base full-cycle clinical data warehouse

rED Cap is easy to use…

• eCRF design by experienced database & SAS® programmers

• Ongoing data review by data analysts & statisticians trained in protocol endpoints

• Customized training designed by experienced data managers & clinical monitors

rED Cap offers professional

design and training…

rED Cap has cost-effective pricing…

• Based upon hours/tasks at competitive rates • Study Administrator: eCRF and report development,

user maintenance and technical support • Data Manager/Analyst – review data collection for

statistical endpoint consistency and accuracy • System Administrator – manage hosting,

configuration, synchronization and database security/integrity

• No license or hosting fees

rED Cap at a glance

AND NOW…

• Use mouse-over tips presented by rED Cap.

• See alert messages as you type.

• If you have questions, just go to the Information Booth. It’s always visible!

Get Help instantly!

• Enjoy an on-line Help Desk with technical support that does not require logging in to the rED Cap study.

• Get an immediate ticket

number assignment. • Get a response within 24

hours.

Use the Contact Help Desk

• Complete tech support form.

• Click submit.

• A ticket number is assigned.

• A confirmation email receipt is sent.

Use the Contact Help Desk

• Get separate URL, user ID and password.

• Select Training Station.

• Choose a Platform.

• Complete Review.

• Print certificate.

Get customized training and support

• Blank eCRF

• rED Cap User Guide

• Examples of other possible entries: • FAQs,

• eCRf Guidelines

• Study specific Information

Customized Information Booth

At the Report Station:

• Standard reports: • Subject disposition

• Query summary

• Outstanding SDV

• Customized reports upon request

• Flexible report format

(HTML, Excel)

• Print or save to PC

Standardized study reports

• Laboratory data

• Diagnostic data

• Photographs/Images

• Device outputs, e.g. glucose meters, etc.

Upload relevant files from a study visit

• See color or mouse-over for text.

• Select Signal Flags to view flags, padlocks and Q’s.

• Select Field Data Status to view Incomplete, Complete, Pending SDV, Frozen and Signed-Off.

Enjoy user-friendly operation

• Current protocol

• Instructions for use

• Guidelines

• Training materials

• Specific study forms/logs

• Source document templates

Share documents by study and site

• Select Document Station. • Click on ‘+’ to expand. • Click on icon to

download or save to your PC.

View or download documents

• Select Document Station

• Click on “Upload”

• Browse and attach file

• Add a description

• Click here to save

• Add additional files to existing uploads

Upload documents to share

• Monitoring Report templates

• Complete reports

• Expense reports

• Monitoring forms and tools

Share documents within sponsor team at the Monitor Station

• Select Query Station.

• Filter by Site, Open, Answered or Closed Queries.

• Sort and print listing.

• Use one click to answer Query directly into the eCRF.

Queries are easy!

• Listing

• Multiple columns per row

• Tabular

Even eCRF layout is flexible...

• Select subject station

• Check the CRF Tool Box

• Click on the ‘folder’ icon

• View subject’s completed CRFs

• Click on print

Need a paper CRF for the file?

• Stations, flags, status and icons on the left

• Study # and site/PI in header

• Filter by Status, use search for subject, and page easily.

• Click on Subject # to view visits

• Each visit tab contains all the eCRFs for that visit

How do I navigate rED Cap?

• Select Subject Station

Note: This listing is customizable

• Click on Add a new Subject.

• Enter and Submit.

• rED Cap will not allow you to enter the same I.D. twice!

• Next....

Ready to add a subject?

• Click on your subject.

• All the Required Visit tabs will appear.

• Enter in any visit order desired.

• Follow rED Cap’s prompts, tips and messages.

…Subject Station

• The Common Form tab contains forms/logs that may/may not be needed.

• Multiple forms may be entered for each subject.

• Select “Adverse Events.”

• Enter data, submit and click Add: Adverse Event to add more.

Enter an AE

• Select a site

• Click the Message Tool

• Automatically creates an e-mail with lists of incomplete fields and outstanding queries.

• Edit to add more information.

• Sent to coordinator roles at site.

• Blinded copy sent to monitor’s e-mail.

Message to the Site

Other Features in rED Cap

• CFR 21 Part 11 compliance with audit trails and e-signature

• Double-data entry system for paper CRF or hybrid studies

• Excel data exports allowed by permission

• Sophisticated third-party access/viewing and entry system

• Ability to design powerful validation checks, create calculations, and disable entry fields and forms according to protocol requirements

Special Tools in rED Cap

• Ongoing import of external data into special eCRF for viewing and reporting.

• Manage product inventory with custom designed forms and reports. Inventory data can interface with eCRF.

• Data transfer tool to bring in mapped EMR or other electronic data into the eCRF for ongoing data management and cleaning.

• Special blinded PHI forms with restricted access and export capability.

Get a quote for a project in rED Cap

Do you know your data collection requirements?

Provide your protocol/CRF template to BSI, along with site and user requirements. BSI will provide you with a quote for eCRF design and CRO support.

OR,

are you planning a project but don’t know exactly what you really need?

Just contact us at BSI. Our biostatisticians and

clinical managers will assist you in

protocol development and data collection.

Contact BSI today

Go to www.biostatinc.com and complete a Request for Information form.

Or call us!! 813-979-1619